Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

NCT00319852 | Completed Phase 3

• 1 other identifier: E2I28
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

Brief Summary

The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea. Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination. Secondary objectives

1. 1.Immunogenicity: To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France). To assess and describe the immunogenicity of the study vaccines in both groups.
2. 2.Safety: To assess and describe the safety of the study vaccines after each dose.

Conditions

Pertussis; Diphtheria; Poliomyelitis; Tetanus

Keywords

Diphteria;; Tetanus;; Pertussis;; Poliomyelitis;; acellular

Outcome Measures

Primary Outcomes (1)

• To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines.

  1 month post-vaccination

Study Arms (2)

1

EXPERIMENTAL

Biological: DTaP-IPV combined vaccine

2

ACTIVE COMPARATOR

Biological: DTaP vaccine

Interventions

DTaP-IPV combined vaccine BIOLOGICAL

0.5 mL, IM

Also known as: TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis

1

DTaP vaccine BIOLOGICAL

0.5 mL, IM

Also known as: DTaP vaccine (CJ purified PDT vaccine ™)

2

Eligibility Criteria

• Age: 56 Days - 70 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born at full term pregnancy (\>37 weeks) with a birth weight ≥ 2.5 kg
• Informed consent form signed by the parent(s) or other legal representative
• Able to attend all scheduled visits and to comply with all trial procedures

You may not qualify if:

• Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination
• Planned participation in another clinical trial during the present trial period.
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
• Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
• Chronic illness at a stage that could interfere with trial conduct or completion.
• Blood or blood-derived products received in the past or planned administration during the trial (including immunoglobulins).
• Any vaccination in the 3 weeks preceding the first trial vaccination.
• History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically).
• Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases with the trial vaccine or another vaccine.
• Thrombocytopenia or a bleeding disorders contraindicating intramuscular vaccination
• History of major neurological diseases or seizures.
• Known family history of congenital or genetic immuno-deficiency.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Whooping Cough; Diphtheria; Poliomyelitis; Tetanus

Interventions

Tetanus Toxoid; Diphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Clostridium Infections

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Pertussis Vaccine; Bacterial Vaccines; Diphtheria Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Study Officials

• Clinical Trials

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 16, 2012

Record last verified: 2012-04

Locations

KR (1)